Astonea Antifungal Cream Tolnaflate

Astonea Antifungal Cream Tolnaflate
SPL v1
SPL
SPL Set ID 12efcacd-2066-f25c-e063-6294a90a4dc0
Route
TOPICAL
Published
Effective Date 2022-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Petrolatum Ceteth-20 Cetostearyl Alcohol Chlorocresol Light Mineral Oil Propylene Glycol Water Sodium Phosphate, Dibasic, Monohydrate Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-05

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50567-7

When using this productavoid contact with the eyes

Section 50570-1

Do not use on children under 2 years of age unless directed by a doctor

Warnings

For external use only

Directions

adults and children 2 years of age and over:

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Children under 2 years of age: consult a physician

Questions?

Toll Free 1-866-326-1313

Active Ingredient

Tolnaftate 1%

Other Information

store between 20° to 25°C (68° to 77°F)

  • do not use if tube seal under cap is broken
Inactive Ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, propylene glycol, sodium metabisulfite, water

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks
Principal Display Panel 35.4 G Tube Carton


Structured Label Content

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of itching, burning and cracking
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50567-7 (50567-7)

When using this productavoid contact with the eyes

Section 50570-1 (50570-1)

Do not use on children under 2 years of age unless directed by a doctor

Purpose

Antifungal

Warnings

For external use only

Directions

adults and children 2 years of age and over:

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Children under 2 years of age: consult a physician

Questions?

Toll Free 1-866-326-1313

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)

  • do not use if tube seal under cap is broken
Inactive Ingredients (Inactive ingredients)

ceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, propylene glycol, sodium metabisulfite, water

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks
Principal Display Panel 35.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)